Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment

Migraine Without Aura Clinical Trial

Official title:

Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814189
• Other study ID #: SB-045
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2013
• Last updated: July 28, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year

• Subjects who have mean frequency of 2-8 migraine attacks per month.

Exclusion Criteria:

• Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine

• Uncontrolled hypertension (diastolic blood pressure >95 mm Hg or systolic blood pressure >160 mm Hg)

• History or clinical evidence of cerebrovascular or cardiovascular disorder

• Renal impairment or dialysis dependence

• Serious illness (physical or psychiatric disorders)

• Drugs and alcohol abuse

• Pregnancy and breastfeeding

• Allergy or hypersensitivity to promethazine or triptans

• Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Sumatriptan+Promethazine (SPr)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Neurology, Emam Hossein Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete headache relief	The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.	At 2 hours after first dose	No
Secondary	Complete headache relief	The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.	At 0.5 hour, 1 hour, and 4 hours after first dose	No
Secondary	Headache improvement.	The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.	At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.	No
Secondary	Using the second dose of study medications.	The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours	At 2-48 hours after first dose.	No
Secondary	Using rescue medication between 2 and 48 hours postdose	The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 / 3.	At 4-48 hours after second dose.	No
Secondary	Rate of headache recurrence	The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours.	At 2-48 hours after first dose.	No
Secondary	Occurrence of adverse events.	Presence or absence of adverse events occurred 4 hours after first dosing.	At 4 hours after first dose.	Yes